Orlando López

21 CFR Part 11

Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry

• Gebundenes Buch

Produktbeschreibung

Covering regulatory requirements stipulated by the FDA, this book delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance with worldwide computer systems validation regulations. The author introduces supporting technologies such as encryption and digital signatures and places regulatory compliance within the context of quality assurance. He demonstrates the importance of integrating validation activities into the system lifecycle using a structured top-down approach. He covers practical applications of quality assurance and engineering techniques as they relate to the development of systems fit to meet user and regulatory requirements.

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Produktdetails

• Verlag: CRC Press
• Seitenzahl: 260
• Erscheinungstermin: 15. Januar 2004
• Englisch
• Abmessung: 260mm x 183mm x 19mm
• Gewicht: 692g
• ISBN-13: 9780849322433
• ISBN-10: 084932243X
• Artikelnr.: 22338010

Autorenporträt

López, Orlando

Inhaltsangabe

Covering regulatory requirements stipulated by the FDA, this book
delineates the organization, planning, verification, and documentation
activities and procedural controls required for compliance. The author
introduces appropriate supporting technologies such as encryption and
digital signatures and places regulatory compliance within the context of
quality assurance. He demonstrates the importance of integrating validation
activities into the system lifecycle using a structured top-down approach.
The material is presented through practical applications of quality
assurance and engineering techniques as they relate to the development of
systems fit to meet user and regulatory requirements.